Two Jury Verdicts Worth $83M Over Pelvic Mesh Reversed

Two Jury Verdicts Worth $83M Over Pelvic Mesh Reversed

Introduction

On Tuesday, a three-judge appeals panel reversed two verdicts worth $83 million awarded to two women who alleged that they suffered severe complications from pelvic mesh medical devices.

The New Jersey appeals court panel had consolidated both the cases and overturned the verdicts based on one important issue, which was common to both cases. The verdicts were awarded by two separate Bergen County juries to the plaintiffs over their claims against Johnson & Johnson (J&J) and its subsidiaries and C.R. Bard, Inc. and its subsidiaries.

In the first case brought against Ethicon Inc., Ethicon Women's Health and Urology, Gynecare, and J&J, a Bergen County jury had awarded the woman and her husband $5 million in compensatory damages and $10 million in punitive damages. The jury held the defendants liable under independent theories of defective design and inadequate warning under New Jersey product liability laws.

The second case had resulted in $33 million in compensatory damages, along with stipulated medical expenses, and another $35 million in punitive damages. The jury held C.R. Bard, Inc., Bard Medical Division, and Bard Urological Division responsible for design and failure to warn defects claims.

The defendants appealed for their cases respectively and raised arguments over evidentiary and substantive parts. However, the panel rejected those arguments and concluded that the verdicts were misjudged by categorically excluding any proof that defendants had obtained what is known as 'Section 510(k)-clearance' from the U.S. Food and Drug Administration (FDA) for the devices.

Ethicon Physiomesh is a flexible, composite, macroporous, and partially absorbable mesh made of non-absorbable polypropylene by Johnson & Johnson. FDA approved the use of Ethicon Physiomesh in March 2010 for the repair of hernias and other fascial deficiencies that require the addition of strengthening or bridging material to obtain the desired surgical result. A hernia is a condition that occurs when an organ, intestine, and/or tissue squeezes through a hole or weak point in the surrounding muscle or connective tissue. The number of hernia repair operations performed every year in the USA is remarkable.

Despite the already existing mesh implants in the market, the sale of Ethicon Physiomesh increased after the FDA approval as it was promoted as a physiologically well-designed device, offering strong and comfortable healing and giving an exceptional intraoperative handling benefit. But within a few years, Ethicon globally recalled the Physiomesh after thoroughly considering the data which was revealed out of Hernia registries.

The appeals court further noted that although courts in other jurisdictions have excluded 510(k) evidence from jury trials involving the design and safety of mesh devices, there is sufficient probative value of such evidence under N.J.R.E. 401 to justify informing the jurors, without extensive elaboration, that the products were reviewed by the FDA under the 510(k)-clearance process before selling.

The panel reversed both jury decisions and remanded the cases for new trials over the Rule 104 hearings on the 510(k)-clearance evidence.